BEUDAMED
    FDA Enforcement Class II Ongoing

    DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic

    Recall: Z-0107-2024 · Reported October 18, 2023

    Enforcement

    Recall Number
    Z-0107-2024
    Event ID
    93023
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 18, 2023
    Initiation Date
    September 12, 2023
    Classification Date
    October 12, 2023
    Address
    1000 Lake Hazeltine Dr, N/A, Chaska, MN, 55318-1037, United States

    Description

    DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic

    Reason

    The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System (LIS, host), the sample barcode presented may be ignored and replaced with a sample ID that was previously in the same rack and position. This will cause a delay of result to the sample currently presented to the system (Sample B) and may result in an erroneous test result for the prior sample (Sample A), which gets associated with the results of sample B.

    Code Info

    UDI/DI 15099590732103, All DxI 9000 Access Immunoassay Analyzer running software version 1.15 or prior

    Distribution

    Worldwide - US Nationwide distribution in the state of Florida, and the countries of Croatia, Czechia, France, Germany, Ireland, Italy, Netherlands, New Zealand, South Africa, Spain, Switzerland, United Kingdom of Great Britain and Northern Ireland.

    Quantity

    36 units